¿ Acadia Pharmaceuticals Inc., of San Diego, withdrew its initial public offering. The company filed for its IPO in December, then set its price range at $13 to $15 per share and the amount of shares at 5 million in February. The company focuses its drug discovery and development efforts on target-specific, small-molecule drug candidates using its technology platform integrating genomics, chemistry and biology to identify and validate drug targets and discover chemistries specific to those targets. (See BioWorld Today, Dec. 27, 2000.)
¿ Advanced Viral Research Corp., of Yonkers, N.Y., said the FDA cleared the company¿s investigational new drug application for Phase I trials of Product R as a topical treatment for genital warts. Product R is a nontoxic peptide nucleic acid-type immunomodulator that may stimulate the proinflammatory responses required to fight viral infections and to dampen aberrant autoimmune-type inflammatory responses.
¿ CytRx Corp., of Atlanta, released results from experimental studies investigating the combination effect of its developmental-stage drug, CRL-5861 (purified poloxamer 188), with the anticancer agent paclitaxel. The studies showed CRL-5861 increased the antitumor effect of paclitaxel without any noticeable increase in toxicity.
¿ AltaRex Corp., of Waltham, Mass., said it completed its 345-patient pivotal OvaRex trial. Data still need to be evaluated. Primary results from the trial will form the foundation of AltaRex¿s biologics license application with the FDA for marketing approval of OvaRex MAb. Submission of the BLA is expected to begin by year-end or early 2002. The trial was conducted at 51 sites in the U.S. and Canada and enrolled patients in an advanced stage of ovarian cancer, following first-line treatment of surgery and chemotherapy. Interim results from the trial were positive. (See BioWorld Today, May 15, 2001.)
¿ Aviron Inc., of Mountain View, Calif., said it received a complete response letter from the FDA relating to its biologics license application submitted on Oct. 31, 2000, for FluMist for the prevention of influenza in healthy children and adults. The FDA requested additional information and clarification regarding clinical and manufacturing data from the company in support of licensure of the product. Aviron said it is optimistic that it will be able to respond to the FDA¿s requests without conducting additional clinical trials. An FDA panel in July said the product appeared efficacious but it had safety concerns. (See BioWorld Today, July 30, 2001.)
¿ BTG plc, of London, reported obtaining exclusive rights from Genentech Inc., of South San Francisco, to develop an atrial natriuretic factor (ANF) peptide technology, shown to have therapeutic potential in treating acute congestive heart failure, acute renal failure and renal hypertension. BTG is looking to license the technology. The ANF technology consists of synthetic peptides that mimic the naturally occurring ANF hormone and regulate diuretic, natriuretic and vasodilatory activity in mammals. Terms were not disclosed.
¿ Chemeq Ltd., of Bentley, Australia, said the FDA will propose fast-tracking Chemeq¿s application for its product, Chemeq polymeric antimicrobial, an alternative to using human antibiotics in animals. Chemeq also is making applications to regulatory authorities in Australia, New Zealand and South Africa. Chemeq is scheduled to begin commercial-scale manufacturing of the product in the next 12 to 18 months.
¿ Endovasc Ltd. Inc., of Montgomery, Texas, reported the acquisition of Intermed 2000 Inc., of Ra¿anana, Israel. Intermed 2000 will become a wholly owned subsidiary of Endovasc. Holders of Intermed 2000 securities will receive shares of Endovasc common stock in the merger. Endovasc develops liposomal drug delivery technology. Intermed 2000 focuses on women¿s health care services and medical technologies. Terms were not disclosed.
¿ Epicyte Pharmaceutical Inc., of San Diego, and Dow Chemical Co., of Midland, Mich., formed an agreement with Centocor Inc., of Malvern, Pa., to evaluate production of a therapeutic human monoclonal antibody in plants. Terms were not disclosed. This agreement is the first license of Epicyte¿s Plantibody technology in the pharmaceutical industry. Centocor has the option to enter into an exclusive commercial supply agreement for a variety of clinical indications. Using an antibody developed by Centocor, Dow will produce the antibody using Epicyte¿s technology for producing human monoclonal antibodies in plants. Dow will provide its proprietary gene expression technologies, crop production expertise and corn processing capabilities.
¿ GeneData AG, of Basel, Switzerland, and diaDexus Inc., of Santa Clara, Calif., signed a license agreement for the GeneData Expressionist microarray data analysis system. This system is designed to rapidly screen through functional genomics data in order to determine genes that are the basis for disease. Terms were not disclosed.
¿ Genta Inc., of Berkeley Heights, N.J., said the FDA granted Genasense, its lead anticancer compound, orphan drug status for three additional cancer indications. The designations apply to applications for patients with multiple myeloma, acute myelocytic leukemia and chronic lymphocytic leukemia. Genasense previously had been granted orphan status for the treatment of patients with malignant melanoma.
¿ Human Genome Sciences Inc., of Rockville, Md., initiated a Phase II trial of repifermin for the treatment of mucositis in patients undergoing chemotherapy for multiple myeloma prior to autologous hematopoietic stem cell transplantation. Repifermin also is undergoing Phase II trials for mucositis in patients under other cancer therapy regimens. The new trial will be a double-blind, dose-escalation crossover study and will enroll 80 patients.
¿ Hybridon Inc., of Cambridge, Mass., said that investigators at the National Cancer Institute and the National Institute on Aging demonstrated that GEM 231, the company¿s antisense drug candidate for cancer, downregulates the expression of its target ¿ RIalpha subunit of protein kinase A ¿ in cell structure and in a tumor model of prostate cancer. GEM 231 is designed to decrease the production of this protein in order to inhibit the abnormal growth of malignant cells.
¿ ID Biomedical Corp., of Vancouver, British Columbia, said its licensee, Applied Biosystems Group, of Foster City, Calif., has made an undisclosed payment for the maintenance of its right to use ID Biomedical¿s Cycling Probe technology. The technology is a proprietary method of signal amplification for the detection of a nucleic acid target. The license allows Applied Biosystems to use Cycling Probe technology in a number of areas, including genomics, high-throughput screening and the development of assays to detect nucleic acid sequences.
¿ InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said Zeria Pharmaceutical Co. Ltd., of Tokyo, licensed exclusive rights to InKine¿s Visicol in Japan. Zeria will develop Visicol as a bowel-cleansing agent. InKine will receive an up-front license fee of $500,000 and an additional $2 million in fixed license fees upon reaching certain development milestones. Additionally, Zeria will pay InKine an undisclosed royalty based on net sales of Visicol. Zeria will be responsible for all development costs.
¿ Janssen Pharmaceutica Products LP, a unit of Johnson & Johnson, of New Brunswick, N.J., filed with the FDA for approval of a long-acting injectable formulation of Risperdal. If approved, it would be the first atypical antipsychotic medication available in a formulation allowing use every two weeks instead of daily, it said. The drug formulation uses Cambridge, Mass.-based Alkermes Inc.¿s Medisorb technology, which involves encapsulation in microspheres made of a biodegradable polymer. Alkermes would manufacture the product if it is approved. Janssen said similar filings are being made worldwide.
¿ Jomed NV, of Beringen, Switzerland, and OxiGene Inc., of Watertown, Mass., formed a collaboration to research restenosis inhibitors, integrating Jomed¿s stent technology with OxiGene¿s platform of vascular targeting agents. Under terms of the arrangement, Jomed will perform proof-of-concept studies using OxiGene¿s vascular targeting agents (VTA) on drug-eluting stents. The experiments will be designed to assess the efficacy and safety of the VTAs in preventing restenosis.
¿ LifeSpan BioSciences Inc., of Seattle, said Sanofi-Synthelabo, of Paris, became the fifth subscriber to its database of information on the expression and localization of G protein-coupled receptors. The contract calls for the number of GPCRs in the database to double from 160 to 320. Terms were not disclosed.
¿ NeoPharm Inc., of Lake Forest, Ill., said it has developed user-friendly formulations for products across its NeoLipid drug delivery platform. The company said the formulations allow for faster and easier reconstitution of NeoLipid products in the pharmacy. The NeoLipid platform uses the company¿s electrostatic liposome technology to encapsulate and deliver a broad range of drugs. Currently, NeoPharm has seven anticancer drugs in various stages of development using the NeoLipid system.
¿ NeoTherapeutics Inc., of Irvine, Calif., said Societe Generale, of France, fully converted and redeemed its $2 million NeoTherapeutics preferred stock investment. Societe Generale acquired the shares through the exchange of $2 million of preferred stock in NeoGene Technologies, NeoTherapeutics¿ functional genomics subsidiary. The investor converted $1.7 million of its convertible preferred NeoTherapeutics stock into common stock, and NeoTherapeutics repurchased the remaining preferred shares at face value for $300,000. The transactions, combined with a recent purchase of a $5 million convertible financing from two other institutional investors, eliminate all outstanding convertible preferred stock and other instruments containing resets or floating conversion features. The transactions also have increased NeoTherapeutics¿ ownership of NeoGene Technologies to 89 percent from 75 percent.
¿ Ortec International Inc., of New York, said the FDA has approved its OrCel bilayered cellular matrix for healing donor site wounds in burn victims. Ortec said the projected market could be in excess of $100 million. The company filed a premarket approval application with the FDA in March. In addition, Ortec is pursuing FDA approvals for venous and diabetic skin ulcers and currently is in clinical trials for these indications.
¿ Pharmacyclics Inc., of Sunnyvale, Calif., reported preliminary results from its ongoing Phase I clinical trial of photoangioplasty with Antrin (motexafin lutetium) injection, indicating the treatment is feasible and well tolerated in patients with coronary artery disease. The drug and light-dose escalation study was designed to evaluate the safety in patients with blocked coronary arteries. No major treatment-related angiographic or biochemical adverse effects or abnormalities were observed and no dose-limiting toxicities were noted. The Phase I study, which is being conducted at seven centers in the United States, will enroll about 75 patients.
¿ Protherics plc, of Macclesfield, UK, said DigiFab for the treatment of digoxin toxicity has been approved by the FDA. This is the company¿s second FDA product approval in less than a year. Its rattlesnake antivenom was approved last October.
¿ Stressgen Biotechnologies Corp., of Victoria, British Columbia, reported additional preliminary Phase II data on HspE7 from the first 56 consecutive patients at the primary six-month evaluation point, when 40 of 56 patients, or 71 percent, downgraded to low-grade dysplasia. The results are from an open-label Phase II trial of the 500-mcg high dose in high-grade anal dysplasia. The company said HspE7 could potentially eliminate the need for surgery in many patients. Final data from the completed Phase II randomized, double-blind, placebo-controlled trial will be presented at the upcoming Interscience Conference on Antimicrobial Agents and Chemotherapy annual meeting in Chicago.